Kornimate/medical-research-clean huggingface dataset:
phase iii clinical trial of npb-01 in patients with stevens-johnson syndrome/ toxic epidermal necrolysis unresponsive to corticosteroids.

Conditions: Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis

Summary: patients diagnosed with stevens-johnson syndrome and toxic epidermal necrolysis were confirmed based on the investigators national diagnostic criteria. patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive npb-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. subsequently, efficacy of npb-01 for therapy of stevens-johnson syndrome and toxic epidermal necrolysis will be evaluated the disease evaluation score et al. as a safety endpoint, the safety of npb-01 will be investigated the occurrence of adverse events by 20 days after the start of the study treatment.


Eligibility criteria:
inclusion criteria: 1. patients who the disease evaluation score is more than 14 at study medication received. 2. patients with corticosteroids over 20mg/day(prednisolone) at study medication received and continued this treatment more than 2 days. 3. patients with treatment effect is insufficiency before study medication received and need additional treatment. 4. patients aged more than twenty years old at informed consent. exclusion criteria: 1. patients who the scorten score is more than 4 at study medication received. 2. patients with multiple organ failure at study medication received. 3. patients with severe respiratory disorder at study medication received. 4. patients with drug-induced hypersensitivity syndrome (dihs) at informed consent. 5. patients with malignancy during treatment at informed consent. 6. patients treated with corticosteroids dosage is change at 2 days before study medication received. 7. patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2 days before study medication received. 8. patients treated with plasmapheresis at 2 days before study medication received. 9. patients treated with high-dose intravenous immunoglobulin at 28 days before informed consent. 10. patients with history of shock or hypersensitivity for npb-01. 11. patients with iga deficiency. 12. patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et al. 13. patients with more than 2mg/dl serum creatinine. 14. patients with severe cerebro- or cardiovascular disorders. 15. patients with high risk of thromboembolism. 16. patients with hemolytic/hemorrhagic anemia. 17. patients with severe decreased cardiac function. 18. patients with decreased platelet less than 75,000/μl..

Keywords: ivig in stevens-johnson syndrome toxic epidermal necrolysis patients with stevens-johnson syndrome toxic epidermal necrolysis unresponsive to corticosteroids
brain imaging, nutrition, and cognition in breast cancer survivors

Conditions: Breast Cancer

Summary: up to 78% of women diagnosed with breast cancer experience impairments in their cognitive function (e.g., frequent forgetfulness, slow processing speeds, and difficulties in concentration, multitasking and/or word retrieval) in the course of cancer treatment. these cognitive impairments (ci) have negative effects on patients' social relationships, overall life satisfaction, and treatment adherence. dietary intake may be an important factor in mitigating risk of ci that breast cancer patients experience. several studies have suggested that dietary intake of specific nutrients and foods (e.g., carotenoids, b-vitamin, and omega-3 fatty acids rich foods) can be helpful to decrease the severity of cancer-related cognitive impairment (crci). high-quality dietary patterns can be also helpful to protect white matter volume and its integrity; damage to and changes in white matter contributes to crci. however, despite the high incidence of crci in breast cancer patients, very little is known about etiology of crci. thus, the purpose of this observational study with cross-sectional design is to examine the relationships of diet with brain structural and functional outcomes of breast cancer patients. the study will aim to enroll 30 female postmenopausal breast cancer survivors (age 45-75) who have recently completed chemotherapy treatment within 3-12 months from study enrollment. participants will complete study questionnaires online, and will have an in-person study visit to complete a functional magnetic resonance imagine (mri) scan, cognitive testing, and blood sample collection via fingerstick and venous blood draw. it is expected that this study will advance the field's understanding and ability to early assess, manage, and prevent crci.


Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer diagnosis * between 3-12 months post-treatment with anthracycline or taxane-based chemotherapy * postmenopausal (at least 12 months without menses; or on ovarian suppression medication; or status post oophorectomy) * english speaking exclusion criteria: * women who have permanent ferromagnetic metal in the body, a pacemaker, or have severe claustrophobia * women who are pregnant or breastfeeding * diagnosis of dementia, psychosis, alcohol or substance use disorders * concurrent other malignancy or metastatic malignancy of any kind * unable to give informed consent.

Keywords: chemotherapy cognitive impairment breast cancer survivor diet
comparing vr and balance exercises in rehabilitation of adolescent athletes

Conditions: Sport Injury

Summary: ankle sprains are common injuries in active young people. most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. high ankle sprains and fractures are much less common but more serious. they may require imaging and more treatment.

phases of rehabilitation for ankle sprain phase i treatment involves resting and protecting the ankle to permit healing, to prevent further injury, and to control pain and swelling. phase ii treatment begins once pain and swelling have subsided to the point where the athlete can comfortably bear weight and walk from place to place. virtual reality (vr) is a simulated experience that can be similar to or completely different from the real world. applications of virtual reality can include entertainment (i.e. video games) and educational purposes (i.e. medical or military training). other, distinct types of vr style technology include augmented reality and mixed reality. biodex balance training is one of the main tool that used to assess dynamic balance and dynamic limits of stability also it can used as training tool to improve the participant balance training

Eligibility criteria:
inclusion criteria: 1. children will have sustained lateral ankle sprain (grade ii). 2. their age was ranging from 13-16 years 3. all children with stable medical and psychological status. 4. they will able to follow the verbal commands or instructions during testing. exclusion criteria: 1. children with ankle or foot deformity 2. unstable medical and psychological status. 3. children not able to follow the verbal commands or instructions during testing 4. children with any disorder affecting balance.

Keywords: balancetraining, virtual reality, ankle instability.
analyst treadmill study

Conditions: Ischemic Heart Disease

Summary: the objective of the study is to collect information on the naturally occurring variations in st deviations at different heart rates, as detected by the analyst and analyst accel implantable cardioverter defibrillators (icd).


Eligibility criteria:
inclusion criteria: * patient has received or is scheduled to receive a st jude medical analyst or analyst accel icd; * patient has documented ischemic heart disease. exclusion criteria: * patient has an indication for ventricular pacing; * patient has chronotropic incompetence or insufficiency; * patient has a contraindication to stress testing; * patient is physically unable to complete the stress test protocol; * the patient has persistent or permanent atrial fibrillation (af); * patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason; * patient is pregnant; * patient is minor (\< 18 years old).
candle - a study of acute health effects of exposure to particles generated by candles

Conditions: Inflammatory Response; Symptoms and Signs

Summary: introduction: particle contamination is suggested to have substantial negative effects on health, with candles emitting huge amount of particles, thus being one of the largest contributors to indoor air pollution. chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like people suffering from respiratory diseases such as asthma. aim: in a randomized controlled cross-over trial the difference in health effects between two candles i) a standard candle and ii) a low emission candle modified from the standard candle is studied.

introduction; particle contamination is suggested to have substantial negative effects on health, with candles emitting the huge amount of particles, thus being one of the largest contributors to indoor air pollution. chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like children and the elderly or people already suffering from allergies and respiratory diseases such as asthma. aim: to study the difference in health effects between two candles i) a standard candle and ii) a low emission candle modified from the standard candle. the following hypothesis will be examined: short-term exposure to particles generated by the standard candle is associated with more objectively measurable effects in metabolomics inflammation compared to exposure to modified low-emission candle particles. methods: separated by two weeks 20 young asthmatics will be exposed in a randomized cross-over double-blind study under controlled conditions in a climate chamber to three different exposures; a) a standard (scandinavian) stearin candle, b) a modified low emitting version of the same candle, and c) clean air from the adjacent chamber. the experiment will be carried out in groups of 3-6 participants. measurements: tsi p-trak ultrafine particle counter and smps will be used for particle counts. health effects, including spirometry and fraction of exhaled nitric oxide (feno) will be evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure. analysis: mixed methods approach taking both time and exposure into account.

Eligibility criteria:
inclusion criteria: * age 18-25 * medically treated / physician diagnosed mild seasonal asthma gina guidelines step 1 or 2 (https://ginasthma.org/) * never smoker or ex-smoker ≥ 6 months * allergy \> 1 common allergy exclusion criteria: * any other disease that could influence the study parameters * conditions that prevent safe access to the climate chambers (such as claustrophobia) * perennial asthma * need for continuous medical treatment for asthma * pregnancy

Keywords: stearin candle health effects inflammation asthmatics particle contamination indoor air pollutant
study assessing the effects of darunavir/ritonavir or lopinavir/ritonavir on the pharmacokinetics of daclatasvir in healthy participants

Conditions: Hepatitis C

Summary: the purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com key inclusion criteria: * healthy male and female participants, aged 18 to 49, as determined by medical history, physical examination, 12 lead electrocardiogram, vital signs, and clinical laboratory evaluations key exclusion criteria: * any significant acute or chronic medical illness; donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only); or blood screen findings positive for hepatitis c antibody, hepatitis b surface antigen, or hiv-1 and hiv-2 antibodies
irinotecan in patients with advanced metastatic breast cancer who have experienced failure of an anthracycline, a taxane, and capecitabine

Conditions: Breast Neoplasms

Summary: the purpose of this phase ii, randomized, open-label clinical trial is to study 2 schedules of single-agent irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. patients will receive irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.


Eligibility criteria:
inclusion criteria: * women with diagnosis of primary adenocarcinoma of the breast * presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent * at least one measurable lesion \>20mm (or \>10 mm with spiral ct scan) * must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting * women at least 18 years old, with performance status 0-2 exclusion criteria: * prior treatment with another topoisomerase i inhibitor * current enrollment in another clinical trial
efficacy study of paclitaxel versus irinotecan in patients with recurrent or metastatic gastric cancer who progress following first-line therapy

Conditions: Gastric Cancer

Summary: the primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (pfs), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed gastric adenocarcinoma in tissue/cell * recurrent or metastatic gastric cancer that has progressed following first- line therapy * patients must be ≥18 years of age. * ecog performance status ≤ 2 * at least one lesion (measurable or non-measurable but evaluable) according to recist criteria * normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: haemoglobin ≥ 9.0 g/dl white blood cells (wbc) ≥ 3000/µl absolute neutrophil count (anc) ≥ 1500/µl platelet count ≥ 100 x 103/µl total bilirubin ≤ 1.5 x upper normal limit (unl) creatinine clearance ≥ 60 ml/min or serum creatinine ≤ 1.5 x unl ast (sgot)/alt (sgpt) ≤ 2.5 x unl unless liver metastases are present in which case it must be ≤ 5x unl * life expectancy ≥ 12 weeks. * written informed consent * provision of informed consent for genetic research (in case of optional genetic research) exclusion criteria: * more than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting. * treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used). * any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting. * patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years. * patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). * ongoing toxicities (\>ctcae grade 2) caused by previous cancer therapy. * clinically proven gastric outlet obstruction or ctcae grade 3 or grade 4 upper gi bleeding * medically uncontrolled, clinically significant heart disease or infection * patients with symptomatic uncontrolled brain metastases. * major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. * women who have pregnancy potential or willing to pregnant. pregnant and breastfeeding women. * others poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. inappropriate patient for subjects of this study on investigator's judgment

Keywords: gastric cancer paclitaxel irinotecan
cns growth factors release and changes in the inflammatory environment in response to electrical stimulation in subjects with inflammatory myelopathies

Conditions: Inflammatory Myelopathies

Summary: this research is being done to see how different amounts of functional electrical stimulation (fes) affect cycling on factors in blood and spinal cord in people with spinal cord inflammation.

fes cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. the fes cycling in this study will be done through a device called the rt300-sl cycle ergometer (rt300). although this device has been cleared by the food and drug administration (fda) for use by individuals with neurological disorders, we are trying to find out the best way to use it in order to obtain the greatest results.

Eligibility criteria:
inclusion criteria: * male, female, age 18-65, all ethnic groups * history of inflammatory myelopathy with onset at least 3 months prior * no fes ergometer (i.e. rt300 or equivalent) use within 1 month * subject is medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues * subject is legally able to make own health care decisions * access to telephone with texting capabilities * english language proficiency exclusion criteria: * cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke new york heart association (nyha) class iii or iv, history of arrhythmia with hemodynamic instability. * uncontrolled hypertension (resting systolic bp\>160mmhg or diastolic bp \>100mmhg consistently) * concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability * unstable long bone fractures of the lower extremities * subjects who are unwilling to agree to two cerebrospinal fluid (csf) examinations (lumbar punctures) * presence of cardiac pacemaker and/or defibrillator * presence of cancer * history of epileptic seizures * subjects having a stage 2 or greater sacral decubitus ulcer * women who are pregnant * active drug or alcohol use or dependence

Keywords: tm ms spinal cord injury functional electrical stimulation rehabilitation growth factors cytokines
effect of early initiation of evolocumab on lipid profiles changes in patients with acs undergoing pci

Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Summary: investigators aimed to evaluate efficacy and safety of early initiation of evolocumab and combination lipid-lowering agent (statin + ezetimibe) on lipid profiles changes in patients with acs undergoing pci

recently, studies have reported that strong ldl cholesterol lowering through pcsk9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. however, the ldl cholesterol reduction effect on statin is different from that of westerners and asians, and studies on the ldl cholesterol reduction effect of koreans on the early use of pcsk9 inhibitors are insufficient. therefore, we would like to study the effect of reducing ldl cholesterol by administering evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.

Eligibility criteria:
inclusion criteria: 1. over 19 years old 2. patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form. 3. patients who underwent percutaneous coronary stenting for acute coronary syndrome exclusion criteria: 1. patients who have previously taken statins, 2. patients with active liver disease or patients with three times or more increase in ast or alt 3. if you have an allergic or hypersensitivity reaction to evorucumab, statin, or ezetimib, 4. pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 5. the remaining life expectancy is expected to be less than a year. 6. subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment 7. subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Keywords: acute coronary syndrome low-density-lipoprotein pcsk9 inhibitor
coreg and hsrs-updated analysis

Conditions: Hypersensitivity

Summary: a cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial post-launch period of carvedilol extended release. in follow up to this observation, product labeling for both agents was updated and a nested case control study was subsequently conducted to examine the risk of serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who used carvedilol extended release compared to carvedilol and separately compared to other long acting beta(β)-blockers. this proposed analysis is an update to the previously conducted analysis using the same database, labrx, now containing 2 additional years of data, which should provide a larger number of carvedilol extended release exposed subjects.


Eligibility criteria:
inclusion criteria: * at least one prescription claim for a β-blocker during follow-up time available in the database. * at least one month of enrollment in the healthcare plan exclusion criteria: * none

Keywords: carvedilol propranolol hypersensitivity reactions beta- blockers coreg
efficacy and safety study of esomeprazole 20mg qd vs ranitidine 150mg bid in patients with an nsaid-induced gastric ulcer

Conditions: Gastric Ulcer

Summary: the purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (nsaid)therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent. * a clinical diagnosis of a chronic condition that requires daily nsaid treatment for at least 2 months. * daily nsaid dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally; exclusion criteria: * history of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. * history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.

Keywords: nsaid-associated gastric ulcer